Home SPL Set DailyMed Isotretinoin Capsules, Usp Isotretinoin Capsules, Usp SPL v2 SPL SPL Set ID dae33df0-386c-4db5-9759-7096e770ed17 Route ORAL Published Effective Date 2023-09-01 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Isotretinoin (10 mg) Inactive Ingredients Alcohol Ammonia Butylated Hydroxyanisole Edetate Disodium Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Gelatin Glycerin Hydrogenated Soybean Oil Isopropyl Alcohol Polyethylene Glycol 400 Polyvinyl Acetate Phthalate Propylene Glycol Soybean Oil Titanium Dioxide Water White Wax Identifiers & Packaging Pill Appearance Imprint: 1025 Shape: oval Color: brown Color: yellow Size: 11 mm Size: 12 mm Size: 14 mm Score: 1 Marketing Status ANDA Active Since 2023-09-12 Description . Medication Information Description . Section 42229-5 . Package Label.principal Display Panel NDC 70771-1557-8 Isotretinoin Capsules, USP 10 mg 30 Capsules Rx only NDC 70771-1558-8 Isotretinoin Capsules, USP 20 mg 30 Capsules Rx only NDC 70771-1559-8 Isotretinoin Capsules, USP 30 mg 30 Capsules Rx only NDC 70771-1560-8 Isotretinoin Capsules, USP 40 mg 30 Capsules Rx only Structured Label Content Section 42229-5 (42229-5) . 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"unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {"42229-5": ".", "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1557-8 Isotretinoin Capsules, USP 10 mg 30 Capsules Rx only NDC 70771-1558-8 Isotretinoin Capsules, USP 20 mg 30 Capsules Rx only NDC 70771-1559-8 Isotretinoin Capsules, USP 30 mg 30 Capsules Rx only NDC 70771-1560-8 Isotretinoin Capsules, USP 40 mg 30 Capsules Rx only"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:43:59.014427 · Updated: 2026-03-14T22:18:18.443233
